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e-CFR data is current as of September 16, 2020

Title 21Chapter ISubchapter HPart 890Subpart D → §890.3790


Title 21: Food and Drugs
PART 890—PHYSICAL MEDICINE DEVICES
Subpart D—Physical Medicine Prosthetic Devices


§890.3790   Cane, crutch, and walker tips and pads.

(a) Identification. Cane, crutch, and walker tips and pads are rubber (or rubber substitute) device accessories intended for medical purposes that are applied to the ground end of mobility aids to prevent skidding or that are applied to the body contact area of the device for comfort or as an aid in using an ambulatory assist device.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in §890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of §820.180, regarding general requirements concerning records and §820.198, regarding complaint files.

[48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38817, July 25, 2001]

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